As the US Food and Drug Administration (FDA) slowly clears through its backlog of work and unfinished tasks in the wake of the 1-16 October 2013 government shutdown, two allergenic product manufacturers are finally getting an advisory committee date for their products, one month after FDA canceled their original meeting.
During the shutdown, FDA was only able to continue operations if it was deemed essential, or if user fees had already been paid for a product. While Stallergenes' Oralair and Merck's Grastek had been submitted long before the shutdown began, the user fee programs do not cover allergenic extract products like Oralair and Grastek. Those products are instead covered under Section 351 of the Public Health Service (PHS) Act, and not the Federal Food, Drug and Cosmetic Act.
As a result, their review is covered by funds appropriated to the agency, which were not available during the shutdown.
And while the original meeting was scheduled for 6 November 2013, FDA informed both companies on or about 8 October 2013 that the meetings would need to be postponed "due to the US government shutdown."
Focus speculated at the time that the move could be an indication that FDA anticipated being strained for resources-notably time-in the aftermath of the shutdown, and that its staff would not have sufficient time to prepare for the meeting if they were furloughed (as they were).
If that was indeed the case within FDA, there are signs that constraint is now easing. In a 1 November 2013 Federal Register notice, FDA said it had rescheduled the Advisory Committee meeting date for Stellergenes and Merck. The meeting will now take place on 11-12 December 2013.
On 11 December, the committee will discuss Stallergenes' Oralair, which is a sublingual allergy tablet intended to treat sweet vernal, orchard, perennial rye, Timothy and Kentucky bluegrass mixed pollens.
On 12 December, the committee will discuss Merck's Grastek, a Timothy grass pollen allergen extract tablet for sublingual use.
Background materials will be made available to the public two days in advance, FDA said.
The news is something of a mixed bag for Merck and Stallergenes. While their products will be at least a month late in getting to market, the good news is that they'll have an extra month to prepare for the meeting.
Federal Register Notice